Events

Retiro De Equipo (Recall) de Active Care 1015-1 Swivel Sliding Transfer Bench

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Active Medical Supplies Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00711-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00711-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    It has been reported that failure or cracking of the seat is visible once the transfer bench has been pulled apart. signs of the plastic cracking around the bolt creating a weak point in the frame and the potential for a similar incident to occur.This recall action was carried out prior to approval of the recall strategy by the tga.
  • Acción
    Active Medical Supplies are completing a modification to affected devices to correct the issue.

Device

Active Care 1015-1 Swivel Sliding Transfer Bench

Manufacturer

Active Medical Supplies Pty Ltd